무방부제성 플루오로메토론 0.1% 점안액의 안구건조증에서의 효과 및 안정성 비교
Efficacy and Safety of Topical Unpreserved 0.1% Fluorometholone Ophthalmic Solution on Dry Eye Syndrome
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목적: 건성안에서 무방부제성 플루오로메토론 0.1% 점안액의 효과와 안전성을 알아보고자 한다. 대상과 방법: 경증 혹은 중등도의 건성안을 대조군(Group I), 무방부제성 플루오로메토론 0.1% 점안액군(Group II), 방부제 함유 플루오로메토론 0.1% 점안액군(Group III)으로 나누어 2주, 4주, 8주, 12주에 안압, 눈물막파괴시간, 각결막표면형광염색검사, Ocular surface disease index (OSDI), 눈물삼투압검사를 측정하여 추적관찰하였다(시험 1). 중등도이상에서 1% 메칠프레드니솔론 단독요법군(Group I)과 무방부제성 플루오로메토론 0.1% 점안액으로 교체군(Group II)으로 나누어 동일한 방법으로 추적 관찰하였다(시험 2). 결과: 시험 1에서 Group II은 다른 두 군에 비해 각결막표면형광염색검사에서 2주, 4주째에 의미 있게 호전되었다(p＜0.05). 시험 2에서는 두 군간에 유의한 차이 없이 비슷한 증상개선효과를 얻을 수 있었다. 결론: 무방부제성 플루오로메토론 0.1% 점안액은 경증과 중증의 건성안에서 유의한 증상 개선효과를 보였고, 방부제 함유 점안액에비해 비교적 안전하게 사용할 수 있었다.
Abstract
Purpose: To evaluate the efficacy and safety of topical unpreserved 0.1% fluorometholone (FML) ophthalmic solution in patients with dry eye syndrome. Methods: Patients with mild to moderate dry eye syndrome were divided into the control group (Group I), topical unpreserved 0.1% FML group (Group II), and topical preserved 0.1% FML group (Group III). Intraocular pressure (IOP),Ocular Surface Disease Index (OSDI), tear film break-up time (TF-BUT), Oxford stain score (OSS), and tear osmolarity (Tosm) were evaluated at 2 weeks, 4 weeks, 8 weeks, and 12 weeks (Trial 1). Patients with severe dry eye syndrome were divided into 1% methylprednisolone (MP) group (Group I) and 0.1% unpreserved FML group (Group II). Same parameters were evaluated in both groups (Trial 2). Results: In clinical trial I, OSS scores of Group II were lower than other groups (p < 0.05). For severe dry eye patients in clinical trial 2, there were no significant differences in all parameters between the 2 groups. Conclusions: Topical unpreserved 0.1% fluorometholone was shown to be an effective and relatively safe treatment in patients with dry eye syndrome.
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